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Guidance

University of Michigan Human Research Protection Program Operations Manual (OM) -- The OM is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and others.

All 'key personnel' must complete basic human subjects education in PEERRS prior to IRB approval of a study. Click here for details. (PDF)

To find guidance on particular topic search for the word on this page using the "Edit" "find" function in the browser toolbar, or use the search box above right, or click on the letter to jump to the alphabetically listings below:

A-B, C-D, E, F-H, I, N-P, R, S-T, U-Z

A-B

Adverse Event Reporting
Advertising (see Recruitment Advertising below)
Assent (see Children, Assent below)
Belmont Report--Ethical Principles
Billing (see Clinical Research Billing Unit)
Blood Draw Guidelines

C

Certificate of Confidentiality Kiosk (NIH Web site)
- Certificate of Confidentiality Frequently Asked Questions (NIH)
Children in Research (also see Neonates)
- Assent (pediatric subject's agreement to participate in research)
  - Assent Template (MS Word) recommended for children ages 10- to 14-years-old
  - Assent Template Announcement
  - Assent Guidelines (PDF) --tool for IRB reviewers and investigators when determining if assent should be required
  - HHS Office of Human Research Protections (OHRP) FAQ on child/parent disagreements on participation
  - National Cancer Institute Guidance (helpful information for all types of research)
- Federal Regulations and Guidance for Children, HHS Office of Human Research Protections (OHRP)
- Federal Regulations for research involving children, HHS Food and Drug Administration (FDA)
- OHRP Frequently Asked Questions
- Research involving greater risk than 'minor increase over minimal' without direct benefit for subjects --OHRP Guidance for 45 CFR 46.407
- Food and Drug Administration 'Pediatric Drug Development' Guidance
- Wards of the State as Research Subjects
Clinical Research Billing Unit
Clinical Trials Registration (ClinicalTrials.gov information)
Complaints from Subject or Others about a Research Study
Consent (see Informed Consent)

E

Eligibility Screening
Embryonic (human) Stem Cells
Emergency Use of Test Articles
Emergency Research with Exception from Informed Consent (PDF)
eResearch
- Basic Step-by-Step Manuals:
- Frequently As Questions
- Guidelines for Stacking Documents (MS Word)
- Glossary of eResearch Terms
- Pre-submission Checklist--Things to have, information to gather before starting a submission
- Quick Reference Card
- Tips--Miscellaneous ways to optimize eResearch
Exempt Research
Expedited Review
Expiration Date (see General Guidelines)

F-H

FDA information about INDs or IDEs see Investigational New Drug Application or Investigational Device Exception below
Federal Regulations
- 21 CFR 50 Regulations enforced by the Food and Drug Administration (FDA)-- Protection of Human Subjects
- 21 CFR 56 FDA--Institutional Review Boards
- 45 CFR 46 Regulations enforced by the Department of Health and Human Services Office of Human Research Protections (OHRP)
Fees for IRBMED Review of Sponsored Projects
Fetuses
Foster children (see Wards of state)
General Guidelines
- University of Michigan Human Research Protection Program Operations Manual (OM)--The OM is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and others.
Genetic and DNA Based Research
HIPAA Guidance
- HIPAA and Research - IRBMED Quick Guide (PDF)
- Helpful Links to Other Sites
- Privacy Board (forms and information)
- Questions about HIPAA
  - General questions about mandatory education, education web site, HIPAA processes or regulations
  - Questions about IRBMED HIPAA documents, applications, and processes click here

I

IDE (see Investigational Device Exemption below)
IND (see Investigational New Drug Application below)
Informed Consent Guidance
- Additional Required Elements under HIPAA (PDF)
- Approval Dates on Informed Consent Documents (PDF)
- Children (see above, Children in Research, Assent)
- Emergency Research with Exception from Informed Consent (PDF)
- Frequently Asked Questions (OHRP)
- Guidelines for Stacking Documents in eResearch (MS Word)
- Non-English Speaking Subjects
- Process
- Simplification Guide to Medical Terms (Glossary)
- Telephone (see Telephonic Consent)
- Template-What's New
- Tips on Preparing Understandable Informed Consent Documents
- Waiver under OHRP, FDA & HIPAA Regulations (PDF)
- Who can Consent or Provide Permission for Participation in Research (PDF)
International Research
- IRBMED Help Guide on International Research
- International Compilation of Human Subject Research Protections (PDF document listing the laws, regulations, and guidelines that govern human subjects research in many countries around the world)
- Miscellaneous International Resources at DHHS Office of Human Research Protections (OHRP)
Investigational Device Exemption (IDE) Application
- Decision tree to determine if an IDE is required
  - Continued Decision tree to determine if an IDE is needed for Custom or Diagnostic Devices
Investigational New Drug (IND) Application
- Decision tree to determine an IND is required (PDF)
- Bioavailability or Bioequivalence Studies--Decision tree to determine if an IND is required (PDF)
Investigator Responsibilities
- FDA Guidance--Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators (PDF)
- OHRP FAQs

N-P

Neonates
Other Reportable Events and Information (ORIO Reporting)
Payment to Research Subjects
Prisoners and Research
- Federal Guidance (Office of Human Research Protections (OHRP))
- OHRP FAQs
- New study enrolling prisoners (OVPR Web site)
- Subject becomes a prisoner / Study not previously approved to recruit prisoners seeks to enroll new subject who is a prisoner
Privacy Board (forms and information)
Protocol Deviations, Exceptions, Violations

R

Radiation Exposure Guide
Research Billing (see Clinical Research Billing Unit)
Record Retention--How Long to Research Records
Recruitment Advertising
- Advertising--General Information
- Guidelines for Non-Study-Specific Subject Recruitment Communication
Removal of Blood
Reports to or from Oversight Agencies, Boards, Committees, etc. (e.g. DSMB, FDA)
Risk--Guidelines For Using Magnitude Of Harm In Categorizing Risk Level

S-T

Signatures on Applications
Standard Operating Procedures (PDF)
- University of Michigan Human Research Participants Protection Program Operations Manual (Draft)
Telephonic Consent
Test Articles in Research
- Biologics and Vaccines
  - General Information
  - Study Design
- Charging for Investigational Products
- Investigational Drugs
  - General Information
  - FDA IND Contact List (to determine if an IND is needed for off-label drug use in research or for a new drug, herb, or nutritional supplement)
  - Study Design
- Investigational Devices
  - General Information
  - Significant Risk, Non-significant Risk Device Distinctions
- Software Guidance (software may require an investigational device exemption from the FDA)

U-Z

Unanticipated Problems involving research subjects or others
Vulnerable Populations (links to HHS Office of Human Research Protections)
Wards of the State as Research Subjects
What's New on Applications
What's New on the Consent Template